Unacceptable on what ethical basis? @fdatobacco surely recognises the reality-based world of youth doing risky things, whatever FDA wants? When kids who would otherwise have smoked take to #vaping instead, there is a clear public health benefit. Preventing that causes harm. 1/7

There is something disturbing about this argument, beyond the obvious indifference to the health and wellbeing of young people from more disadvantaged backgrounds. It’s an attempt to simplify the world by declaring a moral posture rather than deal with the world as it is. 2/7

And why do this? Because @FDATobacco’s favoured #vaping policies - e.g. banning e-liquid flavors and bullying @JUULvapor - are impossible to justify if #ecigs are reducing youth smoking. So that potential benefit can’t be recognised. 3/7

Given regular vaping is highly concentrated in adolescents who smoke; many adolescents give ‘harm reduction’ reasons for vaping; and benefits to a smoker who switches to vaping is far greater than cost to a never-user who takes it up, a net benefit to *youth* is quite likely. 4/7

This destroys the youth-based narrative and political foundations of @FDATobacco’s ‘tough-guy’ stance on vaping. They might be doing harm to youth as well as to adults. And it certainly can’t show it would not cause harm - especially given the rapid declines in youth smoking. 5/7

The problem for @SGottliebFDA is that the public health test in the Tobacco Control Act does not adopt this moral posture. It does not allow FDA to be a cause of greater harm through poor policy simply because its leaders wish the world was different to how it is in reality. 6/7

So, it is helpful to have this reasoning - however perverse - on the record. Ruling out, a priori, a whole category of important benefits in the rule-making process will not stand up to legal or ethical scrutiny. 7/7

2. How much do "sugary drinks contribute to the global rise of noncommunicable diseases"? What is their share of calories in the diet? (Not much). What is the relationship between calorie intake and bodyweight? (Not simple). Between bodyweight and NCD burden? (Not what you think)

3. But even that is not good enough - you also need a counterfactual. If sugary drinks didn't exist, what would people drink, eat or do instead? (e.g. eat more chocolate), and what disease burden would that create? Then compare. A virtually impossible calculation.

More on the slow death of a dream. Telegraph #Brexit briefing is softening up the faithful for the inevitable permanent fudge, hinting at another five years in the customs union (and, necessarily, in the single market). This ‘interim period’ would, in practice, never end. 1/10

So the resolution of the Cabinet squabble over future customs arrangements is, “customs partnership and *then* #maxfac” so the government can do what it does best: avoid making the choice. 2/10

But UK and EU tariffs will not diverge in practice because of the preposterous tracking requirements this would trigger under the customs partnership. Fox can’t sign trade deals until this works, which it won’t - and no one will even try if it is merely an interim. 3/10

Related threads

Assuring the safety of medical products is central to FDA’s consumer protection mission. In today’s #FDA#SUNDAYTWEETORIAL I’m going to talk about FDA’s ambitious new safety goal for medical devices and our 510K reforms that, once implemented, will advance safety and innovation.

We've set a new goal that WE WILL achieve: Ensuring #FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices. This is a top priority. Many have asked me what does that mean? And how will #FDA do that?

First, a little background: #FDA regulates more than 190,000 different medical devices that are manufactured by more than 18,000 companies in more than 21,000 facilities worldwide. We approve, clear or grant marketing authorization to about 12 new or modified devices every day.

Compounded drugs serve an important medical need for patients who can’t use an FDA-approved medication. In today’s #FDA#SUNDAYTWEETORIAL, I’m going to talk about what FDA is doing to preserve access to appropriately compounded drugs while protecting patients from serious risks.

In drug compounding, ingredients are combined, mixed or altered to create a sterile or non-sterile medication tailored to a patient - such as those with an allergy who need a drug without a certain dye or a child who can’t swallow a tablet and needs medicine in a liquid form.

But compounded drugs, which aren’t FDA-approved, may pose serious risks if not produced properly, potentially resulting in contamination or medications that do not possess the strength, quality or purity they are supposed to have bit.ly/2G7IpjB

As kids are heading back to school, for this #FDA#SUNDAYTWEETORIAL I’m going to talk about MEASLES and the vital importance of vaccination. You may’ve seen recent news stories reporting cases of measles in parts of the US and EU. Most cases have occurred in unvaccinated people

In 2018 there have been 124 individual cases of measles in 22 states and D.C. Measles can spread when it reaches a community where there are groups of unvaccinated people. And travelers with measles continue to bring the disease into the United States go.usa.gov/xUzwa

Measles is caused by the rubeola virus and is highly contagious. It is normally passed through direct contact or through the air. The virus infects the respiratory tract, then spreads throughout the body, causing a skin rash, fever, cough and runny nose.

For this weekend's #FDA#SUNDAYTWEETORIAL I’m going to talk about what FDA is doing to modernize clinical trials to reduce the cost of drug development, potentially lower drug costs and bring more safe, effective therapies to patients.

FDA’s mission is to both promote and protect public health. For medical products, this means ensuring that they are safe and effective for their intended use. Clinical trials are the primary vehicle for generating the evidence FDA needs to ensure that.

The traditional drug development paradigm calls for 3 clinical trial phases: A small phase 1 tests safety and dosing, phase 2 tests short-term side effects and effectiveness over a range of doses; and the large phase 3 assesses whether the product’s benefits outweigh its risks.

Y’all, this is Carter. He’s 16. He designed this apparel that he’s selling at the Silver Room Block Party today. It’s his first time selling at a festival. He was excited & nervous but very professional. I bought a really dope jacket from him. Chicago youth doing big things.

The text on the shirt is made of reflective material so that it seems to “light up” when you’re walking down the street. I love the jacket I bought. IG is shop.bycarter16 and Carter’s website is here. bycarter.design

SUNDAY TWEETORIAL: For those who follow me, you’ll know that the topic of this week’s #FDA Sunday Tweetorial is among the most critical: food safety. FDA takes our responsibility for assuring safety of the food supply seriously, and food safety is one of my highest priorities

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